CMAJ/JAMC Special supplement
Supplément spécial

 

Clinical practice guidelines for the care and treatment of breast cancer

3. Mastectomy or lumpectomy? The choice of operation for clinical stages I and II breast cancer

The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer:

This guideline has been peer reviewed.

See also:
  • Letter: More on breast cancer guidelines, S.C. Brown

Abstract

Objective: To assist women and their physicians in making the most clinically effective and personally acceptable decision regarding the choice of primary surgery for potentially curable breast cancer.

Options: Breast-conserving surgery (BCS; also referred to as lumpectomy or wide local excision) or mastectomy.

Outcomes: Local recurrence, metastasis-free survival, overall survival, cosmetic results.

Evidence: Systematic computerized citation search using MEDLINE (from 1980) and CANCERLIT (from 1985) databases to September 1995. Nonsystematic review of breast cancer literature until January 1997.

Benefits: Minimization of disfigurement offered by BCS.

Harms: The need for radiotherapy and the greater costs associated with BCS.

Recommendations:

  • For patients with stage I or II breast cancer, BCS followed by radiotherapy is generally recommended. In the absence of special reasons for selecting mastectomy, the choice between BCS and mastectomy can be made according to the patient's circumstances and personal preferences.
  • Mastectomy should be considered in the presence of any of the following:
    1. factors that increase the risk of local recurrence such as extensive malignant-type calcifications visible on the mammogram, multiple primary tumours or failure to obtain tumour-free margins;
    2. physical disabilities that preclude lying flat or abducting the arm, preventing the use of radiotherapy;
    3. absolute contraindications for radiotherapy such as pregnancy or previous irradiation of the breast or relative contraindications such as systemic lupus erythematosus or scleroderma;
    4. large tumour size in proportion to breast size;
    5. the patient's clear preference for mastectomy.
  • The following factors are not contraindications for BCS: the presence of a centrally located tumour mass, axillary lymph-node involvement or the presence of breast implants.
  • Before deciding between BCS and mastectomy, the physician must make a full and balanced presentation to the patient concerning the pros and cons of these procedures.
  • Whenever an open biopsy is performed on the basis of even modest suspicion of carcinoma, the procedure should be, in effect, a lumpectomy, using wide local excision of the intact tumour surrounded by a cuff of tumour-free tissue (by palpation and visual inspection).
  • The following recommendations should be observed to provide optimum clinical and cosmetic results:
    1. Tumour-involved margins should be revised;
    2. Separate incisions should be used for removal of the primary tumour and for the axillary dissection except when these coincide anatomically;
    3. Radial incisions should not be used except when directly medial or lateral to the nipple;
    4. Drains and approximation sutures should not be used in the breast parenchyma.

Validation: The guidelines were reviewed and revised by a writing committee, expert primary reviewers, secondary reviewers selected from all regions of Canada, and by the Steering Committee. The final document reflects a consensus of all these contributors and has been endorsed by the Canadian Association of Radiation Oncologists.

Sponsor: The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer was convened by Health Canada.

Completion date: July 1, 1997

Until the mid-1980s the treatment for stage I or II breast cancer was removal of the breast by total mastectomy together with removal of the axillary lymph nodes. Since then, the evidence from 6 prospective randomized trials has shown that removal of only the tumour, leaving most of the breast intact, results in the same survival as mastectomy.

Breast-conserving surgery (BCS) refers to removal of the tumour along with a cuff of normal tissue while preserving the cosmetic appearance of the breast. BCS is also referred to as lumpectomy or wide local excision. Mastectomy refers to removal of the entire breast, including the nipple and areola complex and the fascia over the pectoralis muscles while sparing the underlying muscles and innervation. Neither BCS nor mastectomy includes removal of the axillary lymph nodes as part of the procedure, but lymph-node dissection is usually also carried out when invasive disease is being treated. (This issue is considered in guideline 4.)

Apart from certain exceptions (discussed further on), the choice between breast-conserving procedures and mastectomy for stages I and II tumours depends on individual circumstances and personal preference. Considerable evidence that has now accumulated regarding survival and local recurrence rates related to both procedures is summarized in this guideline to help patients and their physicians make the most clinically effective and personally acceptable decisions regarding the extent of primary surgery.

Method

These guidelines are based on published evidence from clinical research studies and, where this is lacking, expert opinion. The strength of the evidence is graded as outlined in Levels of evidence. Relevant publications were identified from the author's personal archives and from a computerized citation search using both MEDLINE (from 1980) and CANCERLIT (from 1985) to September 1995, with the key words breast neoplasms and the following subheadings: randomized controlled trials, surgery, therapy, mortality and pathology. To find other published practice guidelines, letters were sent to all provincial cancer agencies, and enquiries were directed to the national cancer agencies in Canada and the United States. Nonsystematic review of the literature on breast cancer was continued until January 1997.

Upon completion of the draft guideline document by the author, it was submitted to a series of iterative reviews and revisions involving a writing committee consisting of 9 members of The Steering Committee on Clinical Practice Guidelines for the Care and Treatment of Breast Cancer, 2 primary reviewers, surgical oncologists with special expertise in breast cancer and all members of the Steering Committee. It was then submitted to 15 secondary reviewers consisting of family physicians, medical, surgical and radiation oncologists, nurses and breast cancer survivors selected from all regions of Canada. Each draft was reviewed by the author of the initial document. The final document was approved by the Steering Committee and reflects a consensus of all these contributors.

Recommendations (including evidence and rationale)

Mastectomy versus breast-conserving surgery and radiotherapy

Before considering which procedure to recommend, the nature and extent of the tumour must be established precisely using clinical and mammographic information (see guidelines 1 and 2). Once the diagnosis of clinical stage I or II breast cancer is established, the choice of surgery can be made based on the information outlined below.

  • For patients with stage I or II breast cancer, BCS followed by radiotherapy is generally recommended. In the absence of special reasons for selecting mastectomy, the choice between BCS and mastectomy can be made according to the patient's circumstances and personal preferences.

Six prospective, randomized, controlled trials have shown that in patients with operable breast cancer, the outcome after BCS with radiotherapy was equivalent to that of mastectomy with respect to distant recurrences and overall survival (level I evidence).1-6 The results of these trials are summarized in Table 1.1-3,5,7,8 The trial with the highest statistical power is the multicentre National Surgical Adjuvant Breast Project (NSABP) protocol B-06, which compared BCS with and without radiotherapy to mastectomy in 1843 women with stage I or II tumours in whom BCS was cosmetically feasible.9 After an average of 12 years of follow-up, disease-free survival and overall survival were still identical in patients treated by BCS with or without radiotherapy and in those treated by mastectomy, although local recurrence was much more frequent when radiotherapy was omitted after BCS (see guideline 6).4 The results of the NSABP B-06 trial came under scrutiny in 1993, after allegations that some fraudulent data had been provided by a study centre. However, when the results were reanalysed without this centre's data, the conclusion regarding the equivalence of the surgical procedures was unchanged.4,10

Since BCS with radiotherapy results in equivalent survival to mastectomy, the choice between them can be exercised on other grounds. The advantage of BCS is that it conserves the breast. The disadvantage is the need for radiotherapy, which in addition to being time-consuming may also be logistically difficult and costly if the patient lives a long way from the treatment facility. Radiotherapy may also cause adverse effects such as swelling, pain, skin pigmentation and fibrosis of the breast (see guideline 6).11,12

According to the studies outlined in Table 1,1-3,5,7,8 after radiotherapy, local recurrence or a second cancer in the same breast may affect 3% to 11% of women over the next 6 to 15 years depending on the extent of surgery, the patient's age and the characteristics of the tumour. This risk is comparable to the risk of recurrence in the chest wall after mastectomy alone (Table 1). However, with increasing use of chemotherapy, current recurrence rates are lower than this: in NSABP protocol B-13 the local recurrence rate dropped from 13% to 2.6% with the use of sequential methotrexate and 5-fluorouracil (5-FU); in protocol B-19 it was 0.6% with the use of cyclophosphamide-methotrexate-fluorouracil (CMF) therapy.13 For women with estrogen receptor (ER)-positive tumours, tamoxifen produced equivalent changes in local recurrence rates.14 Thus, with the increasingly routine use of systemic adjuvant therapies, lumpectomy and radiation therapy provide very adequate long-term local control.

Recurrence of breast cancer necessitates a second and wider excision or even a mastectomy, which can be psychologically distressing and, for some, devastating. To help prevent this possibility one must weigh the impact of an immediate mastectomy, which can also be distressing.

A National Institutes of Health Consensus Conference, which evaluated the information on BCS, stated that "lumpectomy" was the preferred treatment because it provided equivalent survival and preserved the breast.15 Thus, the choice usually can be based on personal preference. However, under certain conditions, as follows, mastectomy is recommended (level IV evidence).

Special reasons for selecting mastectomy

  • Mastectomy should be considered in the presence of any of the following:
    1. factors that increase the risk of local recurrence such as extensive malignant-type calcifications visible on the mammogram, multiple primary tumours or failure to obtain tumour-free margins;
    2. physical disabilities that preclude lying flat or abducting the arm, preventing the use of radiotherapy;
    3. absolute contraindications for radiotherapy such as pregnancy or previous irradiation of the breast or relative contraindications such as systemic lupus erythematosus or scleroderma;
    4. large tumour size in proportion to breast size;
    5. the patient's clear preference for mastectomy.

Increased risk of local recurrence: Mastectomy is usually necessary when the mammogram shows widespread clusters of malignant-type calcifications throughout the breast,14 when there are multiple primary tumours16 or when clear tumour-free margins in excised tissue are not obtained, even after surgical revision of the original excision (level IV evidence). Grossly involved margins are associated with increased rates of local recurrence (level III evidence), and when involved margins are found, further revision or mastectomy is indicated.17 However, when margins are only microscopically involved, the risk of recurrence is less clear.17 Several series reviewed by Solin and colleagues reported no increase in recurrence rates in the presence of microscopically positive margins, but there is no consensus to guide decision-making in this situation.18 Tumour size has been found to correlate with risk of recurrence after BCS in some but not all studies.1,5,19-21

It has been reported that microscopic features such as a poor nuclear grade or extensive intraductal component (EIC) to the tumour are associated with a higher likelihood of local recurrence (level III evidence), and that these histopathologic predictors of local recurrence may be used to select patients for an initial mastectomy.1,17,19,22-24 The treatment of ductal carcinoma in situ is the subject of a separate guideline (guideline 5). However, most of the evidence associating EIC with local recurrence comes from case series where margins were not well controlled or evaluated.24-28 In series where margins were well controlled, EIC was consistently found not to be predictive of local recurrence.9,22,23,29,30 In fact, EIC seems to be a predictor for positive margins.31 Schnitt and colleagues32 found that even with EIC, those patients with clear or only focally positive margins who underwent standard BCS plus radiotherapy had a local recurrence rate similar to that of patients without EIC (level III evidence). It has also been reported that quadrantectomy, an intermediate procedure between total mastectomy and lumpectomy, provides better local control of recurrence than lumpectomy, suggesting that the wider local excision increases the likelihood of obtaining clear margins.33 Thus, as long as complete excision is ensured and clear margins are obtained, the presence of the above-mentioned histopathological risk factors should not influence the choice of surgery.

Contraindications to radiotherapy: In the absence of contraindications, radiotherapy should be a standard adjunct to BCS. In the NSABP trial of BCS versus mastectomy, at 12 years of follow-up the cumulative rates of recurrence following BCS were 10% for those who received radiotherapy and 35% for those who did not (level I evidence).4 However, physical disabilities may prevent the use of radiotherapy; for example, if the patient cannot lie flat, abduct the arm to 90° or place the hand on the forehead. Contraindications to radiotherapy include pregnancy or previous therapeutic irradiation of the breast. There may also be relative contraindications such as a history of systemic lupus erythematosus or scleroderma (see guideline 6). If any of the above situations are present, women should be made aware that the risk of local recurrence is increased without radiotherapy and that this can be avoided by mastectomy.

Large tumour mass: Cosmetic results of BCS depend on the proportion of breast removed, not on the absolute volume of excised tissue. Rarely, a tumour in a small breast may be so large as to preclude an acceptable cosmetic result with BCS. Thus, in this situation a mastectomy should be recommended.

  • The following factors are not contraindications for BCS: the presence of a centrally located tumour mass, axillary lymph-node involvement or the presence of breast implants.

Centrally located tumours: Central lesions carry the same overall prognosis as lateral lesions (level III evidence), and are not a contraindication to BCS.34 These lesions should be removed in the same fashion as peripheral lesions. This may mean removal of part or all of the nipple or areola if necessary, which should be done without regard for the cosmetic result. The primary goal of BCS should be the achievement of clear margins. Even though extra tissue is removed, the shape, sensation and contour resulting from BCS are still greatly superior to those of a reconstructed breast. The nipple may be reconstructed if desired (level IV evidence).

Lymph-node involvement: Studies have shown no difference in survival either node-positive or node-negative women are treated by mastectomy, by BCS or by BCS with radiotherapy (level I evidence).4

Breast implants: The presence of a prosthesis is not a contraindication to BCS provided that the tumour can be removed with clear margins without damaging the prosthesis. Neither is a prosthesis a contraindication to radiotherapy;35 however, radiotherapy probably does increase the risk of fibrotic reaction around a prosthesis (level IV evidence).36

Informed choice

  • Before deciding between BCS and mastectomy, the physician must make a full and balanced presentation to the patient concerning the pros and cons of these procedures.

The body shape is less disturbed after BCS than after mastectomy,37-39 and fewer women experience disruption of their sex life.37,39 However, there is no evidence that women suffer less psychological morbidity or differ in their overall quality of life after BCS than after mastectomy.38-41 In a prospective nonrandomized study of 269 women with stage I or stage II breast cancer, 65% indicated that fear of cancer was their primary fear, rather than fear of losing a breast. Also, 1 year after surgery there was no difference in the presence of anxiety or depression among the women in the BCS and mastectomy groups (level III evidence). However, those patients who were treated by surgeons who offered them a choice between the 2 procedures showed less depression than those treated by other surgeons (p = 0.06).42 In that study, it is uncertain whether the lesser depression was due to the exercise of choice by the patient or that the offering of choice was a marker of a more sympathetic surgeon, another possible cause of less depression. The importance of physicians communicating with patients in terms of the patients' decision-making and psychologic adjustment is being increasingly recognized.43,44 Indeed, a correlation has been shown between patients' psychologic adjustment at 6 months and perceived physician behaviour during the interview at which the diagnosis of cancer was given.44 Thus, discussion of these issues with the patient is vitally important. Communication may be more successful if another family member is present and a written or diagrammatic summary of the pros and cons is given to the patient to review at leisure. (Note that a less technical, patient-oriented summary of these guidelines is available and may serve as a basis for discussion.45)

An informed decision is not usually accomplished in one encounter. The patient should be given time to digest the information and return for a follow-up discussion if she wishes. To allay unnecessary fears it should be explained that taking 1 to 2 weeks to arrive at the best decision will not compromise her chance of cure since, based on our current understanding, the tumour may have been present in a preclinical state for many months or years (level V evidence).

Studies have shown that the surgeon's bias may emerge in such discussions.42,46,47 While it is sometimes important to make a specific recommendation to the patient, the presentation of the evidence behind the recommendation should be fair, balanced and as detailed as the patient wishes.

Surgical technique

The techniques for BCS have been part of surgical teaching for a relatively short time. The lessons learned by surgeons who participated in the early clinical trials were developed in a series of workshops and consensus conferences. Presented below are some of the key technical surgical points which have the endorsement of experienced surgeons in this specialized field (level IV evidence).48

  • Whenever an open biopsy is performed on the basis of even modest suspicion of carcinoma, the procedure should be, in effect, a lumpectomy, using wide local excision of the intact tumour surrounded by a cuff of tumour-free tissue (by palpation and visual inspection).

Many of these tumours can be adequately excised with clear margins at the first session, avoiding the need for a second operation. When this result is not achieved and a biopsy specimen is later reported as containing malignant cells, a second operation is required to excise the tumour or tumour-bearing area and reassess the margins. In this situation, blood and serum will be present in the cavity, discolouring the surrounding normal tissues and causing reactive induration, with the result that the subsequent excision is then not as easy to accomplish and pathological evaluation is not as accurate. The best operation balances the primary need to remove the tumour completely against the secondary goal of achieving the best cosmetic result. Removal of an excessive amount of breast tissue, as in a quadrantectomy, is associated with reduced local recurrence but also with poorer cosmetic results. It has no advantages in terms of avoidance of metastases or death from cancer.14

A clear margin is one with no malignant cells at the cut surface on microscopic examination. In the NSABP clinical trial results quoted earlier, clear margins were obtained but no minimum width was required. At operation, the limits of the tumour can usually be identified on gross inspection. Although frozen section can be useful for the initial evaluation of 1 or 2 uncertain areas, the detailed analysis required for good margin evaluation cannot be accomplished by the frozen-section technique.

The specimen should be orientated for the pathologist, using marking sutures or radiolucent clips. Skin removal is not necessary unless the tumour is immediately subdermal. The pathologist should use the established techniques for painting and assessing the margins.

  • The following recommendations should be observed to provide optimum clinical and cosmetic results:
    1. Tumour-involved margins should be revised;
    2. Separate incisions should be used for removal of the primary tumour and for the axillary dissection except when these coincide anatomically;
    3. Radial incisions should not be used except when directly medial or lateral to the nipple;
    4. Drains and approximation sutures should not be used in the breast parenchyma.

Tumour-involved margins should be revised: If the final pathology report indicates the presence of unsuspected margin involvement, the margins should be revised by opening the original incision and removing several additional millimetres of tissue from the affected margins. Exceptions may be considered when involvement is microscopic and when such intervention would cause significantly poorer cosmesis. Of course, the patient must fully understand that local recurrence may be more likely. As noted above, persistent marginal involvement after revision should lead to consideration of mastectomy.

Separate incisions should be used for removal of the primary tumour and for the axillary dissection except where these happen to coincide anatomically: The lumpectomy incision should be placed directly over the lesion. Tunnelling from a circumareolar incision to a more peripheral lesion raises the danger of incomplete removal and should be avoided. Also, a single incision that is extended to reach the axilla will produce distorted and contracted scars. Generally, incisions should not extend outside the radiotherapy field (midsternum to midaxillary line).

Radial incisions should not be used except when directly medial or lateral to the nipple: Subareolar tumours should be removed through circumareolar incisions. Tunnelling should be avoided. In the upper or lower part of the breast, radial incisions give poor cosmetic results; transverse incisions should be used.

Drains should not be used in the breast and approximation sutures should not be used in the breast parenchyma: In the absence of drainage and approximation sutures the cavity fills with normal wound-healing elements, and the eventual consistency of the breast is indistinguishable from normal tissue.

Contributing authors

 Author of initial guideline document: Richard G. Margolese, MD, The Jewish General Hospital, McGill University, Montreal

Writing committee: Marie-Dominique Beaulieu, MD, Centre hospitalier de l'Université de Montréal, Montreal; Judy S. Caines, MD, Dalhousie University, Halifax; Françoise Bouchard, MD, Health Canada, Ottawa; Ivo A. Olivotto, MD, British Columbia Cancer Agency — Vancouver Cancer Centre, Vancouver; Maureen C. Nolan, MD, Queen Elizabeth II Health Sciences Centre — Victoria Site, Halifax; S. Kishore Thain, MD, Memorial University of Newfoundland, St. John's; Mark N. Levine, MD, McMaster University, Hamilton, Ont; W. Phillip Mickelson, MD, Health Canada, Ottawa; Maurice McGregor, MD (Chair), Royal Victoria Hospital, Montreal;

Primary reviewers: Drs. H.R. Shibata and R.H. Wilkinson

Secondary reviewers: Drs. A.L. Agranovich, D.S. Ahmed, R.M. Baird, N. Craven and J.C. Dort, Ms. N. Grainger, Drs. S.M. Leaghey and L. Lohfeld, Ms. E. Nolan and Drs. B.D. Norris, P.M. Rebbeck, C.A. Sawka, K. Shaw and P. Smith

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[Table of Contents]
| CMAJ February 10, 1998 (vol 158, no 3) / JAMC le 10 février 1998 (vol 158, no 3) |
| CPG Infobase / Infobanque des GPC |